Newsletter June 2010

Transcription

AUSTRALASIAN
LEUKAEMIA
AND
LYMPHOMA
GROUP
AUSTRALASIAN LEUKAEMIA AND LYMPHOMA GROUP
Number 29
Thank you and farewell to the Executive
The outgoing executive “captured” live at their last meeting in Adelaide in May (with two “absentees” looking on). Thank you to (left to
right): Joy Ho, Mark Hertzberg, Devinder Gill, Tony Mills, Andrew Wei, Pauline Warburton, John Seymour, Leanne Berkhan and Ian Lewis.
The whole membership is grateful for your management of the transition to the new structure.
The Executive has focussed on group oversight and supporting day to day matters. They set
objectives to ensure future planning sustains the existence of the group. As the regulatory environment has evolved, they identified the need to better support members in implementing Investigator Initiated clinical trials. The foresight to change the infrastructure resulted in employment of staff to perform those activities that promote haematological research, emphasise
translational research and new technology modalities adjunct to trial protocol framework. The
Executive have worked diligently to improve governance and promote professional integrity.
The implementation of the Board of Management is timely and the Executive Committee will
now be able to focus on specifics of scientific research. The members of the Executive will now
become the members of the Scientific Advisory Committee (SAC). We foresee that once the
transition of the Board and the new SAC is complete that new opportunities for members to
become involved in the ALLG clinical trial program will become available.
On behalf of the staff of the ALLG office I would like to thank the Executive members (past and
current) for their tremendous enthusiasm and industrious work that has to lead us to this point.
Inside this issue:
MESSAGE FROM THE CHAIRMAN OF THE
2
BOARD
TRIAL NEWS
3-7
Delaine Smith, Operations Manager
CML EDUCATIONAL/CML
TRIALS
8-9
2009 Research Report
TRANSLATIONAL NEWS
12
MAY SCIENTIFIC MEETING
HIGHLIGHTS
1415
ALLG ACTIVITIES
1819
GRANT NEWS
23
The Research Report is a compilation of the ALLG trials program, including detailed reports of operational and business activity of this nations leading haematological oncology cooperative group. It also includes specialist disease group summaries from Andrew Wei, Leanne Berkahn and Ian Lewis, Tony Mills, Devinder Gill
and Mark Hertzberg, Pauline Warburton, Joy Ho, and John Seymour, along with full
trials publication listing.. Special thanks to the ALLG Tissue Bank for provision of
images for this report.
Copies are available from the ALLG Website and the ALLG office.
This research report was jointly funded by NHMRC and Cancer Australia grants.
A message from Peter Kempen - Chair
I would like to congratulate the newly
elected and appointed members of the inaugural Board of Management. I feel very privileged to be the Chair of the Board of Management and I am looking forward to working with my new colleagues.
Peter Kempen - Chair
John Mortimore
We are delighted to have been given the
opportunity to assist ALLG and its members
in furthering the goals of the organization.
We are very impressed by the achievements
of ALLG to date and I would like to congratulate the members of the retiring Executive and their predecessors, who have guided
the organization to this point. In particular, I
would like to congratulate John Seymour on
his stewardship of ALLG over the last few
years and Mark Hertzberg for his role as
Treasurer. The group is in excellent shape
and the new Board has a wonderful foundation upon which to build. We are also looking forward to working with the very talented and hardworking ALLG staff members.
Each of the new external members has a
strong personal reason to be part of the future of ALLG. We each bring a range of skills
and experience covering business, corporate
governance, legal, financial, marketing and
philanthropy together with our own networks which should prove useful in enhancing the activities of ALLG. We recognise
that the restructure of ALLG is a significant
step in a journey that started in 1974 and
has been taken on trust by the membership. We hope to manage the change seamlessly, so that the ALLG can further progress in order that it, and its members, are
able to realize their long term goals.
In the last two or three months we have
been learning about the workings of the
ALLG by meeting with the staff, attending
meetings of the Executive and attending a
meeting of the Finance and Audit Committee. We have also been given a vast amount
of documentation to absorb about ALLG.
We realize that we still have a lot to learn
about ALLG, however we are very keen
and we would hope to be able to fully contribute to the future of ALLG within a reasonable period of time. Thank you for giving us the opportunity to contribute to the
very important work of the ALLG and I
look forward to reporting to you on the
Board’s progress in the year ahead.
New ALLG Board
Malcolm McComas
Independent members:
Peter Kempen - Chair
John Mortimore
Malcolm McComas
Geraldine Gray
Geraldine Gray
Page 2
ALLG members:
John Seymour (Chair SAC)
Andrew Spencer
Andrew Roberts
Peter Bardy
Number 29
Trial news
NHMRC grant applications
ALL6 PI: Ken Bradstock
The inferior results of treatment of ALL in adults may be due to differences in disease biology, poorer patient
compliance and treatment deliverability, less dose and time intensive adult treatment protocols, and different
clinical environments. Adults have been shown to have a higher rate of relapse than children with comparable
disease biology features, implying that treatment-related factors must account for at least some of the observed differences in outcome.
Several studies have shown superior outcomes for adolescents and young adult (AYA) patients treated on
pediatric as opposed to adult ALL protocols. Subsequently, 2 large prospective studies used pediatric based
protocols to treat AYA ALL patients; both showed superior results compared to those using protocols designed for adults, although with greater treatment-related toxicity in older patients. It is important to know if
time and dose intensive pediatric protocols can be delivered to older ALL patients in an equivalent timeframe
as for children. However, no study has reported direct comparisons of the deliverability of pediatric ALL
protocols in adult versus pediatric populations. It also remains unclear as to whether intensification of treatment for adults with detectable MRD can improve the poor current outcome of these patients.
This study will therefore test whether dose and time intensive chemotherapy protocols designed for treatment of children with ALL can be administered in an similar schedule to adolescents aged 15-19 and to
younger adults up to 40 years of age. It will also assess whether AYA patients with ALL will have lower levels
of MRD using a pediatric protocol than with protocols designed for adult ALL, but higher than children
treated with the same protocol. Finally, it will test if the outcome of AYA ALL patients identified as having a
high risk of relapse based on pre- and post-treatment prognostic factors can be improved by intensification of
post-induction chemotherapy.
Ken Bradstock
Both these trials
have been the
subject of grant
applications for an
Risk stratified AML PI: Ken Bradstock
NHMRC project
Randomised studies in adult AML by the Australasian Leukaemia and Lymphoma Group (ALLG) have shown a
complete remission rate of over 80% with intensive induction chemotherapy. However, despite these advances, the majority of patients will ultimately relapse. To improve the post-remission outcome of Australian
patients with AML, this trial will address the following hypotheses:
1.That inclusion of information from gene mutation analysis of AML cells at diagnosis, and detection of residual leukemia after therapy, to the traditional prognostic algorithim will enhance the ability to risk stratify
patients with AML.
2.That patients with predicted low relapse risk AML, can be effectively managed with chemotherapy.
3.That patients with high risk disease on the basis of adverse cytogenetics, gene mutation profile, and/or
poor response to treatment will have improved outcome with alloHCT.
4.That patients undergoing alloHCT will have lower transplant-related mortality using reduced intensity
conditioning regimens.
5.That the novel drug lenalidomide used as maintenance therapy will reduce the risk of relapse in patients in
the low risk group, and in high risk patients unable to have alloHCT.
These hypotheses will be investigated through 4 approaches. Firstly, novel molecular markers will be prospectively verified for their ability to stratify patients with a high risk of relapse. Secondly, the prognostic
value of minimal residual disease testing by quantitative molecular testing and flow cytometry will be examined in a prospective, multicentre setting. Thirdly, we will examine whether allogeneic stem cell transplant
can be delivered more safely with reduced intensity conditioning. Lastly, for patients lacking a suitable donor,
we will examine in a randomised manner the value of maintenance therapy with the immunomodulatory
agent, lenalidomide. This trial will implement national standardization of post-remission care of AML through
prospective validation of key questions.
grant. If successful
Page 3
funding would
commence in 2011
Trial News - two successful closed trials
AMLM12 PI: Ken Bradstock
A randomised trial of idarubicin dose esaclation in consolidation therapy following
intensive induction chemotherapy incorporating high dose cytarabine in patients with
untreated adult acute myeloid leukaemia
Trial Manager: Juliana Di Iulio
AMLM12 PI
Ken Bradstock
(we do try to vary the
photo....)
These two AML
trials together
constitute a
landmark in ALLG
AML trial history.
They are the latest
in the ALLG’s
ongoing role of
defining AML
treatment in
Australia
Dose intensification in AML - background to the AMLM12 trial
When the Australian Leukaemia Study Group was established in 1982, it’s primary area was trials in AML.
The group (and its successor the ALLG) have a proud history of defining the standard treatment of AML
through a series of phase III trials. The main focus and philosophy was the broad area of dose intensification.
In the AMLM2 trial conducted 1984 – 87, the question was the addition of etoposide. The treatment comparison involved two arms known as “7-3” vs “7-3-7” – the “7” in the second arm was 75 mg/m2 etoposide
d1-7. The outcome was a demonstration of the remission duration benefit of the addition of etoposide. In
1987-91, the AMLM4 trial, “7-3-7” (with etoposide) now became the standard arm and this was compared
with HiDAC-3-7. In this trial HiDAC involved the intensification of cytarabine to 3 gm/m2 bd days 1, 3, 5, 7.
The outcome of this trial was prolonged remission duration AND increased overall survival. Following this,
the AMLM7 trial in 1995 - 2000 then compared one course of HiDAC-3-7 with two courses. By this time GCSF was available to support treatment for haematological toxicity and made this major dose intensification
possible. The results of this landmark trial included induction CR 80% and 5-year overall survival of >50%.
So between the years 1984 and 2000, by a series of dose intensification trials, the group was able to improve
CR rates and overall survival.
Enter the AMLM12 trial
The AMLM12 trial then set itself the primary question of comparing two consolidation regimens with the
main difference being 2 vs 3 days of Idarubicin. Subsequently, a second randomisation was added, that of
Palifermin vs placebo. The M12 trial opened to accrual in 2003 and resulted in the registration of 442 patients
by the date of closure to accrual on 21 April 2010. The target was 288 patients randomised. As of publication
295 patients have been randomised with a possible one more coming. A total of 23
sites contributed patients and overall the trial definitely kept Trial Manager Juliana
very busy and off the streets. The protocol ended up at version 5 and patients needed
to be reconsented for trial specific testing. One demanding issue was the eligibility of
patients with prior MDS. If MDS was related to prior chemo or radiotherapy the
answer is NO; if unrelated then they are eligible.
Fluffy slippers
For the enjoyment of the fashion conscious we show Juliana wearing her fluffy slippers. Ken is not known to have ever worn any.
AMLM13 PI: Paula Marlton, Andrew Grigg, John Seymour
High dose cytosine arabinoside & fludarabine without anthracycline for core binding
factor AML
Trial Manager: Teresa Morgan
Core-binding factor (CBF) AML, a cytogenetically favourable entity, was the focus of this study which completed accrual in 2009. This phase II study examined the safety of repeated courses of high-dose cytarabine
therapy and the value of minimal residual disease testing to follow the kinetics of CBF AML. The emerging
importance of CBF subsets carrying adverse risk c-KIT and FLT3 mutations and the potential to target these
lesions with novel agents represent important challenges for future strategies in this disease sub-group.
AMLM13 PI
Paula Marlton
An interim analysis as scheduled in the protocol for 12 months after the last patient was registered and commenced treatment (last patient in 19/06/10). The close out date for the analysis is 30/06/10. This means you
need to provide the date of last contact for each living patient on or after 30/06/10, and this should be able to
be collected as part of the study 3-monthly follow-up visits. Please record details on form [M1] for each
patient's expected patient visit between 30/6/10 and 30/09/2010. If the patient has gone off study please
complete form [K]. All participating sites will receive a letter setting this information out. The deadline for
receipt of all outstanding CRFs and current queries in the Trial Centre is
Page 4
7 October. If you anticipate any problems meeting this deadline, please
contact Teresa Morgan as soon as possible.
Number 29
Featured trial
ALL5 PI: Andrew Grigg
A Phase II Study of Dasatinib Combined with Induction Chemotherapy in Previously
Untreated de novo Philadelphia Chromosome-Positive Acute Lymphoblastic Leukaemia
Trial Manager: Glen Wiesner
This trial is currently operating at 7 sites with an accrual of 6 of a target of 20 patients. The concept is
based on a rationale as follows:
1.
The remission rate and more particularly disease-free survival (DFS) is poor in Ph+ ALL. The only
demonstrable curative therapy is allogeneic stem cell transplantation, but this is not available to the
majority of patients with this disease which increases proportionally with age.
2.
Imatinib and combination chemotherapy lead to improvement in remission and short term DFS,
but the relapse rate is high (esp. in the second year of therapy) with no evidence of a plateau in
DFS.
3.
Most relapses are associated with imatinib-resistant BCR-ABL mutations, which are generally detectable at a low level at or early after diagnosis and are presumably “selected out” by ongoing
imatinib (Pfeifer et al, Blood 2007;110:727-734). The authors concluded that the findings provide a
rationale for the front-line use of kinase inhibitors active against these BCRABL mutants.
4.
Most (but not all) of these mutations are sensitive in vitro to dasatinib. This drug has recently been
reported to be effective as a single agent in imatinib refractory Ph+ ALL (Abruzzese et al, Blood
2006;107:4571-2). Nevertheless single agent dasatinib is unlikely to kill all Ph+ stem cells (Copland
et al, Blood 2006;107:4532-9).
5.
The ALLG has completed a study (CMLALL1) in adult Ph+ ALL with imatinib and conventional
chemotherapy. The combination seems to be well tolerated with few overlapping nonhaematological toxicities. Reversible myelosuppression is probably the main clinical issue. The trial
design provides the rationale for a follow-on ALLG study using dasatinib and chemotherapy. It has
been decided to use hyper-CVAD based chemotherapy instead of the LALA protocol used in the
current ALLG study for the following reasons:
►
Hyper-CVAD-imatinib chemotherapy results in Ph+ ALL look promising (Thomas et al, Blood
2004;13:4396-4407) and the dasatinib-HCVAD protocol appears well tolerated (F. Ravandi,
personal communication)
►
The numbers in the Thomas et al study are larger than the ALLG study (only 8 patients treated
on the chemo-concurrent imatinib arm) and hence will enable meaningful comparisons of relevant robust clinical end points such as remission rates and remission duration.
►
The hyper-CVAD protocol is a much less complex protocol which is widely used in Australia
(LALA is not).
The study will evaluate laboratory parameters such as the kinetics of molecular response and the incidence and impact of BCR-ABL mutations. In addition, the trial may enable analysis of the mechanism of
resistance to the approximate 20% of cases of relapsed or resistant Ph+ ALL not due to kinase mutations.
We very much encourage new sites to join in this important and interesting study. Contact the Trial
Manager Glen Wiesner.
Page 5
ALL7
PI Andrew Grigg
Trial Manager: Glen
Wiesner
2 for 1
For every 2
accruals at one site
we will give you a
special prize - an
additional photo of
PI Andrew Grigg!!!
SCREEN YOUR
PATIENTS TODAY
AND WIN!!!
Trial News
New trial
CLL6 PIs: David Gottlieb, Con Tam, Stephen Mulligan
An Australasian, Phase III, Multicentre, Randomised Trial Comparing Lenalidomide Consolidation Vs
No Consolidation in Patients With Chronic Lymphocytic Leukaemia and Residual Disease Following
Induction Chemotherapy
Short Title: RESIDUUM
The newly revised CLL6 protocol is on its way, following numerous changes including in the title, treatment
and laboratory tests.
CLL6 Principal
Investigators
Con Tam
David Gottlieb
Patients with previously untreated or minimally treated CLL requiring treatment (based on standard criteria)
will be registered for this study prior to the initiation of chemotherapy, and a pre-treatment blood sample
sent for flow cytometry, IgVH sequencing and IgVH mutation status determination and FISH analysis. The
patients will then undergo chemotherapy with either FC or FCR at their institution according to local guidelines. Patients will be assessed for residual disease at the end of chemotherapy (following a minimum of 4, and
a maximum of 6, cycles). Patients who have evidence of residual disease (by clinical examination, CT scan [as
defined by lymphadenopathy >1.5cm or persistence of organomegaly], marrow morphology or MRD flow
cytometry) will be eligible for randomisation in this study.
Eligible patients will be randomised in the ratio 1:1 to lenalidomide or observation. Randomisation must occur between 3 to 6 months after the final dose of chemotherapy. Those patient randomised to lenalidomide
will start treatment within 28 days of randomisation at 5mg daily (2.5mg for renal impairment), escalating by
2.5mg every 2 cycles (1 cycle = 4 weeks) until a target of 10mg daily (5mg for renal impairment) is reached.
Lenalidomide treatment will be continued for a total of 2 years. Patients in both arms will be assessed for
MRD using high-sensitivity flow cytometry and ASO-PCR assays.
Target accrual: 192 randomised
Treatment: Lenalidomide – 5mg orally daily, with escalation up to 10mg daily, for 2 years.
Accrual period: 4 years, with 3 years of follow up commencing after the last patient is randomised.
The ALLG is aiming to open this study at 25 sites throughout Australia and New Zealand.
Con and friends
dream a dream at
the May ASM
Page 6
Number 29
Current trials - END OF YEAR SALE!!!
Perhaps you aren’t aware, but all these fantastic trials are all currently open to accrual. EOIs have been
sent but if due to some extraordinary oversight you have not received an EOI and would like to participate then please contact the Trial Manager immediately.
GET YOUR TRIAL TODAY!! YOU’VE GOT TO BE IN IT TO WIN IT!!!!
NHL24 PI: Samar Issa
Primary CNS lymphoma
Trial Manager: Narmatha Kuru
This trial of upfront treatment Mtx 3mg/m2 with randomisation to Teniposide BCNU Prednisone or T
BCNU P plus Rituximab in primary CNS lymphoma is currently receiving expressions of interest to participate. Everyone is keen to get it off the ground quickly. The trial is being run in collaboration with HOVON
(the Netherlands group) and the Australian/NZ target accrual is 80 patients. Email Narmartha TODAY to get
all the lowdown!!!.
NHL24 PI
Samar Issa
ALL7 PI: Ken Bradstock
Phase I study of RAD001 (Everolimus) in combination with chemotherapy for treatment of relapsed adult ALL
Trial Manager: Poppy Kypreos
This is a Phase I open label dose-escalation study to be run at a limited number of ALLG-accredited sites. The
study will recruit a total of 20 evaluable patients. The first cohort of 6 patients will be treated with RAD001
at 2.5mg per day from day 1 through until day 18 with hyper CVAD chemotherapy and followed for at least
21 days. A second chemotherapy cycle of HDMTX and cytarabine may be given to eligible patients to complete the first chemotherapy course. Recruitment of additional patients to either only the 2.5mg/day dose or
to an escalated 5mg/day dose or termination of the trial will be subject to the recommendation of the Trial
Management Committee (TMC). Patients achieving a CR by day 42 of the current RAD001 HyperCVAD
course (d21 of HD MTX cycle) may continue with subsequent courses of the same dose of RAD001 HyperCVAD chemotherapy up to a total of 4 courses.
We aim to open the trial at 14 sites. If you would like to be one of the lucky select group of participating sites
please contact Poppy Kypreos TODAY!!.
MM11 PI: Andrew Spencer
ALL7 PI
Ken Bradstock
(we try REALLY
HARD to vary the
photo....)
A Phase 3, Multicentre randomised controlled study to determine the efficacy and
safety of Cyclophosphamide, Lenalidomide and Dexamethasone (CRD) versus Melphalan (200mg/m2) followed by Stem Cell Transplant in newly diagnosed Multiple
Myeloma subjects
Trial Manager: Nola Kennedy
Accrual is currently 4 of target 100 (international target 380)
Ten sites have ethics approval and a further 18 are undertaking site submissions, but it’s not too late to join
in. The study is steadily accruing internationally, so please contact Nola Kennedy TODAY if your site would
like to JOIN THE RUSH!!!
MM11 PI
Andrew Spencer
Page 7
CML educational for site staff
The latest haematology educational for data managers/research nurses was as usual a resounding success. A
very high-powered team from Adelaide, gave the presentations to an enthusiastic audience of approximately
35 participants on Tuesday 4 May
as part of the May ASM.
Thankyou to Tim Hughes, David
Ross, Debra White, Devendra
Hiwase and David Yeung for their
informative CML presentations.
Left: normal Right: CML
What’s the buzz with OCT1 ?
Deb White’s presentation was particularly interesting. If you want to read more, here are the references.
D White et al. Most CML patients who have a suboptimal response to imatinib have low OCT-1 activity: higher doses
of imatinib may overcome the negative impact of low OCT-1 activity. Blood 2007
D White et al. The functional activity of the OCT-1 protein is predictive of long term outcome in CP-CML
patients treated with Imatinib. JCO (published on-line April 2010)
Summary Oct1 Activity :
• OCT 1 Activity – good predictor of response/identifies the “poor” responders
• A low OCT-1 activity can be partially overcome by an imatinib dose increase, where tolerated.
• Pre-screening for OCT 1 Activity will allow for “customised therapy” for this group.
Summary: imatinib PK
• Non compliance may be a significant determinant of IM response
• A stat plasma IM level may not be all that it seems! Has your patient taken their glivec immediately prior
All the
presentations from
to having their blood taken?
► Don’t rely on a single stat measurement. Repeat assays 7 to 14 days apart are likely to be more informative.
► Measure IM levels pre and 2 hours post dose
the CML
educational day for
data managers/
research nurses in
May can be
downloaded from
the ALLG website
Diagram from:
Apperley J. Lancet Oncology (2007) 1018-1029
Page 8
Number 29
ALLG CML trials update
CML6 PI: Tim Hughes
A phase II study in adult patients with newly-diagnosed chronic myeloid leukaemia of
initial intensified Glivec therapy and sequential therapy for non-responders
The treatment phase of this trial is published but the extension phase continues. In 2004 Version12 amendment was approved by SDMC (‘CML6 Extension Study’). Patients needed to be reconsented to participate in
the extension. V12 requires patients to have increased frequency of testing/visits BUT decreased follow-up to
6years (2years active treatment, 6 year follow-up ie 8 years from study entry). V12 Ext was offered to all 103
patients but only 78 reconsented and they will complete follow-up in August 2011. Some patient data is still
outstanding - it is imperative that all data is submitted to enable accuracy for reporting of the trial.
CML7 PI: Tim Hughes
Phase II trial of Pegasys in glivec responsive chronic myeloid leukaemia
This trial accrued 21 patients (target 20) and closed in 2004. Dr Simon He is looking at a proposal to collect
some long term data on therapy post Pegasys, all bcr-abl results and current status of CML during last followup. The ALLG is currently seeking a funding source to enable Simon to complete and publish this longterm follow-up.
CML8 PI: Tim Hughes
A phase II study of withdrawal of imatinib therapy in adult patients with chronic
phase chronic myeloid leukaemia in stable molecular remission
There are now 34 patients accrued to the trial, with a target of 35-40 being aimed for. The study is still open
and still welcomes participation from new interested clinicians!
CML9 PI: Tim Hughes
A Phase II study in adult patients with newly diagnosed chronic-phase chronic myeloid
leukaemia of initial intensified imatinib therapy and sequential dose escalation followed by treatment with nilotinib in suboptimal responders
Make sure you have the right protocol version: Version 3.0 (Jan 12th 2010) is most current. Cohort 1 recruitment is now COMPLETE. New CML patients will only be able to go onto the trial when the new protocol amendment is approved at your site for Cohort 2.
CML10 PIs: Tim Hughes, Michael Osborne
Response Post Imatinib: Assessment of Sensitivity and Therapeutic Response to Second-Line Therapy in CML: The Australasian RESIST Study
Trial Manager: Bronwyn Cox
Don’t resist but.......GO GO GO!!! The RESIST study is open. Current Accrual: 2
If you would like to participate and have not received an EOI then contact Bronwyn Cox.
Accrual Targets: TKI Registry: 1,000 | STOP Registry: 210
Page 9
Left: the Royal Adelaide CML team, with
Tim Hughes centre
Above: Lauren
Haswell, BaCT
CML Trials Manager
Extraordinaire!!!
Trial Manager for CML6,
CML7, CML8 and CML9
Lauren Haswell
ALLG Tissue Bank
Strategic changes
A key target for the Tissue Bank has been to offer
tissue banking to 90% of all trial patients. We are still
some way off achieving this. As of November 2009
only 20 of approximately 71 ALLG approved institutions (28%) have sent samples for ‘trial related’ tissue
banking. Currently there is no single model in use.
Where there is no sample collection mandated it
relies on use of the separate generic tissue bank consent. In some trials only the trial specific sample collection is integrated and tissue banking is not, or TB is
optional for institutions to include. In others, tissue
banking is integrated with trial sample collection.
Our aim is to integrate sample collection into every
new trial protocol, and also embed tissue banking
consent i.e. have one consent form with an optional
tick box for tissue banking. This will have the crucial
effect of allowing patients to opt out, but not institutions.
The achievement of this goal is dependent on coordination between the TB sample coordinator, TB research scientist and the protocol development officer
while the protocol is being written. The aim is to
refine sample collection and processing requirements
and integrate detailed instructions into the protocol.
To facilitate
patients signing
Tissue Bank
consent form, data
managers and
research nurses
Transition to business model
This will have important implications for all new protocols being developed ie for principal investigators
and also for the Tissue Bank. The scope of work and
budget for each trial will need to be formalised to
ensure that sample costs are included in the budget.
Future viability of the TB mandates cost recovery/fee
for service.
The transition to a business model will mean a formalisation of the quoting process and the policy to cover
this is currently being developed. However there are
a number of issues that need to be addressed.
• Trials vary considerably and one quoting model
may not fit all
• Sample accrual estimates need to be based not
only on patient numbers, but also take into account sample timepoints, patient drop out, etc.
• Front end/set up costs need to be included, which
may incorporate a base fee and project management fee
PwC ALLG Tissue Bank Quoting Template
should ensure ward
Please note, scientific requirements and logistics can be discussed with ALLG Tissue Bank if required.
Trial Name
Trial PI and contact details
Contact for correlative studies
nurses are familiar
Trial quoting for the collection and processing components can be very complex. As a given trial may
have numerous collection time points and at each of
these time points, multiple specimen types may be
collected all of which can have unique sample processing requirements. On top of this, some of the
time points may only involve a proportion of the
enrolled subjects e.g. different treatment arms. Then
there are the storage conditions that need to be
taken into account. For example consider the storage requirements for the NHL24 trial (above), in
which plasma, CSF, tissue and saliva are all planned
for collection at different time points, and with different storage requirements.
A reminder, that the very valuable pro-bono transport provided by Australian Air Express was negotiated for Tissue Banking only. While we have been
able to “piggy back” trial specific tissue bank consented patient samples onto this system, we must be
mindful not to misuse it and risk losing this valuable
contribution.
Policy and Procedure Manual revision
The manual is due for a major revision to bring our
processes into line with the NHMRC Bio banking
information paper published in March this year. Issues
that need addressing include inclusion of international
best practice guidelines, material transfer agreements,
access for non-research or non-approved purposes,
ownership, benefit sharing and cultural sensitivities.
Trial Bank vs Tissue Bank
We have to remember that our TB is processing both
trial specific (Trial Bank) and future research samples
(Tissue Bank). We need to develop an understanding
of the relationships between these two distinct functions. See the diagram on opposite page.
Number of patients relative to this quote
Duration of sample accrual
E.g. 12 months
Study duration
with the generic
E.g. 3 years (2 yrs accrual, 12 months to primary endpoint)
Is Tissue Banking included in this protocol?
Does the Consent form for this trial include Tissue Bank consent?
Yes/No
Yes/No
(please circle)
(please circle)
Please fill out columns below as shown:
consent form
NB. Where more than one specimen type is collected at a single time point, please ensure that you indicate which testing and processing method is required for each
specimen type.
E.g. At Cycle 1 Day 8, Bone marrow and Peripheral blood is collected, gene expressions is required for Bone Marrow sample only. However gene methylation is
required for both Bone Marrow and Peripheral Blood at this time point.
TIMEPOINT
Specimen
Collected
Laboratory
testing to be
performed
*Processing required, number of
cells and cell concentration
required *(additional detail below)
Storage Requirements
(Inc. Std. container specifications)
Final destination of processed
samples if known
E.g.Study Entry
(Baseline)
Bone
Marrow
Flow cytometry
Cryopreserved for viable cells
3x vials @ 5x107 cells per 1mL
Frozen in Liquid Nitrogen Vapour
@ -196 °C in 2mL cryovials
Storage at ALLG Tissue Bank until
end of trial
* For each different processing method required (as listed above), standard processing methods will be used, as defined in SOP s on the ALLG website, please
indicate and specifically detail if processing requirements differ from these default methods. Refer to: www.petermac.org/allg/NewSite/
(If processing methodologies are complex, please attach separate instructions)
Sample Type
Cryopreserved
Processing requirement
E.g - As per website SOP s - cryopreservation for viable cells @ 5 x 10 7 cells per 1mL.
Page 10
Tissue Banking sample collection quote template
Number 29
Trial Bank Vs Tissue Bank
1. To process samples from
trial patients for trial related purposes. These tests
are defined in the protocol
Sample arrives at
ALLG Tissue Bank
Trial Only
Trial and
Tissue Bank
Tissue Bank only
Patient is on a Trial and
has only given Trial Consent
Patient is on a trial and has signed
both Trial and Tissue Bank consent
Non –Trial patient who has
given Tissue Bank Consent
Trial has PRIORITY
The ALLG Tissue Bank has a
dual purpose
Only Excess samples
TRIAL BANK
TISSUE BANK
2. To store samples from trial
and non-trial patients for
future research. This is not
defined ahead of time in a
protocol. Researchers with
suitable projects apply for
use of the samples
Both of these goals are important, but the trial tests have
priority (see diagram at left)
Sample utilisation
Tissue Bank Sample Numbers Allocated to Researchers per Year
Total samples dispatched by February 2010 = 1194
Total sample Number Per Year
TB019
TB018
450
TB017
400
TB015
350
TB014
TB013
300
TB012
250
TB011
200
TB010
TB009
150
TB008
100
TB007
50
TB006
TB005
0
2006
2007
2008
2009
Year Dispatched
2010
TB004
TB002
TB001
[email protected]
Sample Coordinator
[email protected]
STAFF
NOTE: phone prefixes have changed
(Old phone numbers will still work until
2011)
Ms Megan Ellis
ALLG Tissue Bank Manager
07-3176 5835
Dr Lyle McMillen
ALLG Tissue Bank Research Scientist
A PROUD RECORD
The ALLG Tissue Bank has a record to be proud of.
In spite of the well recognised difficulties, we have
achieved the following in our 5 years of existence:
• samples from over 2000 patients delivered and
processed
• approx 45,000 samples made
• processing performed for 17 clinical trials - 10
ALLG, 7 non-ALLG
• samples from 924 non-trial patients banked under
80 WHO classifications
• 503 trial patients also provided samples for tissue
banking
• Of 1427 patients consented for the Tissue Bank,
researchers have already accessed samples from
448 of these patients (31% ). Multiple samples
stored from each patient enables supply for multiple projects.
CONTACT INFORMATION
General email address:
07-3176 5464
Ms Jana Dracopoulos
ALLG Tissue Bank Sample Coordinator
07-3176 5838 or 3176 5836
Mrs Josie Thomas
ALLG Tissue Bank Laboratory Scientist
07-3176 5839
Postal address for samples
Page 11
Attention:
Staff of the PwC ALLG Tissue Bank
Princess Alexandra Hospital
c/- Haematology/Pathology,
Main building level 1
Ipswich Road
Woolloongabba Qld 4102
Translational news
The past year in review
Cytogenetecists meet
Correlative studies in chronic myeloid leukaemia
remain one of the most productive areas of ALLG
activity. Furthermore, in myeloma, one correlative
study for MM6 has been published and the other has
been submitted for publication.
Lynda Campbell reported on meeting held 22nd
March at the Australasian Society of Cytogeneticists
conference in Canberra. Lynda facilitated a meeting
with 60 Cytogeneticists, representing all main labs, to
consider centralised review for all ALLG trials. Fundamental requirement is the means for identifying trial
patients at local cytogenetic labs, along with clear
indication as to when result is needed. Lynda suggests
a trial specific ‘fact sheet’ outlining what’s needed,
timeframes, and agreed classification usage would be
beneficial for the various sites involved. Centralised
review can then be set up so as to determine/convey
trial specific result documentations. It is hoped that
the procedures will be established to implement with
Andrew Wei’s Phase II AML trial.
A major impetus over the past year has been made in
the planning of correlative studies for follow-on clinical trials on AML. The assessment of cytogenetics and
molecular prognostic markers are an essential part of
AML management; significant steps are being adopted
to ensure centralised review of cytogenetics and
quality assurance in the testing of molecular markers.
Studies of Wt-1 and other molecular markers are
continuing in relation to M12 and M13. APML4 has
been completed with excellent accrual and we look
forward to the results of both molecular and arsenic
pathophysiological investigations. For ALL, interesting
proposals are being discussed including various modes
of MRD detection to be incorporated into forthcoming trials.
The CLL studies in relation to OFICIR (CLL5) are
continuing, while new proposals in relation to the
lenalidomide consolidation study, under consideration, are being planned.
Other ongoing studies and studies in preparation
include immune and viral biomarkers in EBV-positive
lymphoma, regulatory T cells in follicular lymphoma,
correlative studies on diffuse large B cell lymphoma
and Hodgkin’s Disease in relation to the PET-directed
trials, including the assessment of microRNA profiles.
Laboratory Science Breakfast
The committee holds a Laboratory Sciences breakfast
meeting at all bi-annual ALLG scientific meetings. In
this face-to-face forum, new studies are discussed,
and the progress of on-going studies reviewed. The
Committee frequently communicates electronically
for the assessment of correlative studies and Tissue
Bank applications.
Molecular Laboratory Network
The proposed estabishment of a molecular laboratory
network is another exciting new development. The
goals are:
• Provide essential molecular testing for ALLG trials.
It is planned to resource this through existing
rebates
• Establsih a QA process
• Network on issues of methodology, turn around
time, etc.
Page 12
Other proposals under development
Other proposals discussed at the recent scientific
meeting include:
• Mutation analysis in AMLM12 using DNA extracted from bone marrow slides
• Flow cytometry and molecular detection and PCR
in ALL6
• Correlative studies for ALL7
These presentations can be dowloaded from the
ALLG website (see page 24).
Laboratory Science Committee
Disease Group Chairs:
Joy Ho
Andrew Roberts (until May 2010)
Maher Gandhi (from May 2010)
Disease Group Committee:
Lynda Campbell, Maher Gandhi, Mark Hertzberg,
Tim Hughes, Bryone Kuss, David Ma, Paula Marlton, Alec Morley, John Seymour, Andrew Spencer,
Annabel Tuckfield, Andrew Wei
Aims:
• To enable correlative studies to be planned
and designed from the inception stage of a
clinical trial
• To encourage the collection of valuable tissue
samples for the ALLG Tissue Bank
• To enable high quality translational studies to
be performed and therefore to maximize the
scientific information that can be derived from
clinical studies
Number 29
Victorian Cancer Trials Link
The Victorian Cancer Trials Link (VCTL) is a searchable database of all cancer clinical trials being conducted in Victoria. All ALLG trials are listed on this
website and can be searched by entering the word
‘ALLG’ under ‘Keyword Search’ or by trial name. Do
you know that VCTL provides an online patient
matching service so that patients and clinicians can
identify all suitable trials that match their clinical
picture? This avoids clinician bias when referring
patients to trials. Officially launched in December
2009, the VCTL provides the most comprehensive
list of all cancer trials in Victoria. At April 2010,
there were almost 700 clinical trials listed , of which
approximately 30% (202) were haematological trials.
The website and database were established when the
Victorian Cancer Agency funded the Victorian Cooperative Oncology Group and the Clinical Trials Office
to develop a clinical trial database to make it easier
for cancer patients and
clinicians to find suitable
clinical trials. It is hoped the
information provided by the
database will enable patients, family members,
carers and health professionals to identify suitable
clinical trials quickly and
easily.
Through this website, Cancer Council Victoria aims to:
• Increase the number of patients enrolled in clinical
trials
• Increase the number and type of active trials available to metropolitan and rural cancer patients
• Improve patient access to new and innovative cancer
treatments via clinical trials offered that may only be
open at one or more selected cancer centres.
Trial registration - update
As of 20 May, there were approximately 108,700 clinical trials registered on ICTRP Search Portal. Our own
ANZCTR has been an important contributor with 4074 records, which is actually the third largest. While nearly
half of all records come from North America, the ANZ contribution is actually the third largest contributor,
which is very impressive considering our much smaller size.
Several very interesting publications are now available on trial registration and related topics, including:
1 Publishing information about ongoing clinical trials for patients. F Godlee, I Chalmers. BMJ 2010;340:c725
2 New Law May Be Having Some Effect on Publication Bias. RTuma. JNCI 2010 102:290-292
3 Reporting bias in medical research - a narrative review. N McGauran, B Wieseler, J Kreis, et al.Trials 2010,
11:37.
4 Influence of trial registration on reporting quality of randomized trials: Study from highest ranked journals.
Reveiz L, Cortés-Jofré M, Asenjo Lobos C, et al Iberoamerican Cochrane Network. J Clin Epidemiol. 2010
Trial registration has been an important step in dealing with publication bias.
For more information about the International Clinical Trials Registry Platform visit their website. For more
information about registration in Australia/NZ visit the ANZCTR.
Page 13
May 2010 Scientific Meeting, Adelaide
All presentations given
accessed through our
ALLG May Scientific Meeting held in Adelaide was
yet another success and we received much positive
feedback from our members. A heartfelt ‘Thank You’
also goes out to all our sponsors for their contributions toward this event (see box on next page).
‘Member Login’ section
Presentations
at the May Scientific
meeting can be
of our website under
‘News & Events’
page. Please note that
these are for your use,
but must not be passed
on.
Reimbursement claims
must be supported by
tax invoices
Bank statements or flight
itineraries are not adequate
for tax purposes and claims
will not be processed without
a Tax Invoice showing:
the ABN of the company
► a description of the
goods or services
► the amount paid and the
►
GST .
All presentations given at the meeting can be accessed through our ‘Member Login’ section of our
website under ‘News & Events’ page. Please note
that these are for your use, but must not be passed
on.
Registrations - for future note
We have made our registration process simpler
through Cvent to avoid walk-ins on the day of the
event. You MUST register through our on-line registration system if you are planning on attending. All
members and data managers/research nurses who
work on our trials will receive an eVite into your
inbox to register. Follow the following four simple
steps to complete your registration:
1. If you are planning on attending, please click the
‘YES’ button/link located at the bottom of your
eVite; If you are not planning on attending, all you
have to do is click the ‘NO’ button/link located at
the bottom of your eVite to avoid receiving
schedule reminders.
2. Complete your contact details – If you have attended past events, your contact details will be
automatically pre-filled and all you have to do is
double check your information and update if
necessary.
3. Choose the sessions that you will be attending –
This is an important part of the process as this
will provide us the final numbers in our planning
process for hotel room set-up and catering.
4. Book hotel accommodation – Be sure to choose
the correct check-in and check-out dates from
the drop down menu and complete the credit
card transaction details to secure your room.
NOTE: You pay for your own accommodation on
arrival at the hotel — your online booking has
reserved your room.
* This completes your registration process and you
will receive a registration confirmation email into
your inbox. Be sure to save this for future reference
as it lists your ‘Confirmation Number’ to view/
modify/cancel your registration.
Reimbursements - deadline 10 August
Please note that reimbursements for the May Meeting will not be accepted after the 10 August 2010,
due to financial reporting responsibilities. The ALLG
Reimbursement Claim Form must be used to receive
funding. The form can be downloaded through our
‘Member Login’ section of our website under ‘News
& Events’ page. Please note the ALLG can only reimburse claims supported by ‘Tax Invoices’.
ALLG dinner - National Wine Centre
Som of the “Top 10” team
with their wine and their
prizes
And the winner is...
Of course the meeting highlights would not be
complete without mentioning the renditions of
Susan Boyle’s song. The winning number was
the outstanding song and dance of the “Top
10” data manager/research nurse table with
this:
“I dreamed a dream of trials gone wrong,
So that is why I sing this silly song.
The eCRF has gone on the blink,
And caused me now to turn to drink.
And then there was the GCP,
Revelation brought me grief.
I dreamed a dream the ALLG…
What a nightmare....”
Page 14
At second place was the “The Underpowered Study”
team with the following ditty:
“I dreamed a dream of trials gone by
When hope was high and life worth living
I dreamed that no patient would ever die
I dreamed that Blood would be forgiving
And Ken was young and unafraid
And Jim Bishop was totally wasted
And BaCT never needed to be paid
No song unsung and no drug untested”
Favourite wines of the outgoing Executive -did you guess right???
See page 27...
PLATINUM
SPONSOR
Number 29
Highlights of the May Scientific Meeting
And a good time was had by all!!
Adelaide marked the first meeting of the ALLG Board and with that the disbandment of the
long-standing Executive committee governance as we know it. The new ALLG Board were in
attendance and made themselves available to chat with clinicians.
Attended by 68 clinicians and 58 data mangers and research nurses, the ALLG Scientific meeting also incorporated education and training in CML disease biology, GCP, QOL and Health
Economics sessions. Small group meetings were held by the BMT disease group, the TB Management Committee, the Lab Science committee and CLLARC group.
GOLD
SPONSORS
New trial proposal highlights
Tony Mills, Chair of Supportive Care, invited Andrew Grigg to discuss two new proposals:
1.
Antiemetic- Emend for R-CHOP Patients receiving R-CHOP chemotherapy for NHL who
have not had any previous exposure to chemotherapy will receive a standardized antiemetic regimen and be randomized to receive aprepitant or not.
2.
Antiemetic- Aprepitant for ABVD HL patients to evaluate the control of nausea and emesis with two anti-emetic protocols, one without dexamethasone and one with the addition
of dexamethasone to a standard aprepitant regime on days 2-3 after ABVD chemotherapy.
This will be evaluated after each two chemotherapy treatments and after the total duration of therapy.
Both proposals are waiting on further progress based on ALLG feedback, feasibility and financial support.
Devinder Gill and Mark Hertzberg, Chairs of the High Grade Lymphoma group, invited
Samar Issa to present new concept of maintenance treatment for patients with relapsed PCNS
Lymphoma. A phase ?I/II? Pilot study of oral Lenalidomide monotherapy in pts with relapsed or
refractory PCNSL. Primary endpoint would be Maximum tolerated dose, and identify toxicity
profile & dose limited toxicity. Concept will progress based on feasibility and discussions with
Celgene regarding maintenance Lenalidomide.
Bortezomib in AL amyloidoisis
Peter Mollee presented a proposal for a phase III trial to test oral melphalan and dexamethasone (MDex), the standard therapy for AL patients who are not stem cell transplant
candidates, against bortezomib added to MDex (BMDex). The basis for the combination of
BMDex includes the high activity of bortezomib in AL, particularly the high complete response
rate and the rapidity of haematologic response to bortezomib and dexamethasone, and the
large clinical experience on the phase II and phase III levels with bortezomib, melphalan and
prednisone in myeloma. The trial, being led by Professor Giampaolo Merlini (current President
of the International Society of Amyloidosis) will attempt to establish a new standard of care
(melphalan, dexamethasone and bortezomib) for this group of patients who so desperately
need effective treatment options. Progress of this study is dependant on international collaboration and identification of funding to support ANZ researchers.
Thank you to all sponsors - see box at right.
Page 15
SILVER
SPONSOR
BRONZE SPONSORS
Centre for Biostatistics and Clinical Trials (BACT)
BaCT to the future - eCRFs and web-based
systems
eCRFs
Paper based CRFs are so familiar to us that it’s
hard to imagine managing to do without them.
Despite hearing about electronic data entry or
eCRFs for ages nothing ever seems to happen. Or
does it.....
Often the reaction to the idea is “Oh no!!!!”. The
data entry burden will be transferred to the sites,
and you’ll need to learn about another system. The
IT system may crash. It will take a longer time to
set up the CRFs at the trial centre ( to start with
anyway).
But let’s look at the “Oh yes!!!!”
Some advantages:
• Immediate queries at the site while you still
have the source data open
•
Fewer queries sent to site
•
Less time spent in getting clean data
•
Quicker time to analysis and reporting
•
Real time review by trial centre and medical
monitor
•
Web-based registration/
randomisation screen
Remote review by medical monitor
There are many issues that remain to be settled on
a trial by trial basis, such as data security, disaster
recovery, audit trail and training requirements. But
the future is already with us....
Web-based registration/randomisation
A new web-based randomisation system has recently been unveiled in BaCT, went live in May in a
phase III trial (non-ALLG). The Data Management
and Analysis Centre (DMAC), The University of
Adelaide was selected to build and host the required system. It features central (user) administration, site administration, patient registration including randomisation allocation and inclusion criteria
and email notification to multiple parties.
Electronica data capture (EDC)
BaCT is also trialling a web-based EDC system called
OpenClinica. This is open source ie freely available
and involves so far 8,000+ community members in 76
countries. The system supports regulatory compliance and standards and is commercially supported by
Akaza Research. The company provides a range of
optional services such as training, hosting and validation for audits.
This sytem also went live in May with a small single
site pilot trial with experienced site data entry staff.
Next steps
Next will be the complete evaluation of the webbased randomisation and OpenClinica systems as
well as the consideration of other EDC systems. It
will be important also to evaluate potential benefits
such as cost, real time data, investigator access,
safety reduction in double handling and accuracy and
timeline improvements.
Implications for ALLG trials???
Watch this space......
(This article is a summary of talks given at the May Scientific Meeting by Linas Silva and Marianne Hundling)
Trial Statisticians
Emma Link
ALL5, AMLM12,
AMLM13, MDS3, NHL11
Alan Herschtal
CML9, SC01, BM07, CLL5,
HD3, NHL21
Richard Fisher
APML4
Gaelle Dutu
CML6, CML8
Yamna Taouk
MM6
Please contact the allocated Clinical Trial
Manager the first instance or otherwise statisticians. For any difficulties or trials not listed
contact one of the following:
Marianne Hundling
BaCT Clinical Trial Program Manager
[email protected]
Dina Neiger
Director
[email protected]
Page 16
Number 29
Want more information about a trial?
For up-to-date information including accrual and all essential documents go to the ALLG website.
Trial Managers
Trial
Status
Trial Manager
Location
Email
Phone No
ALL5
Open
Glen Wiesner
BaCT
[email protected]
03-9656 1878
ALL7
Submitting
Poppy Kypreos
BaCT
[email protected]
03-9656 1268
AMLM12
Follow-up
Juliana Di Iulio
BaCT
[email protected]
03-9656 3786
AMLM13
Follow-up
Teresa Morgan
BaCT
[email protected]
03-9656 3786
AMLM14
Open
Narmatha Kuru
BaCT
[email protected]
03-9656 5807
APML4
Follow-up
Juliana Di Iulio
BaCT
[email protected]
03-9656 3786
BM07
Open
Glen Wiesner
BaCT
[email protected]
03-9656 1878
CLL2
Closed
Narmatha Kuru
BaCT
[email protected]
03-9656 5807
CLL5
Open
Poppy Kypreos
BaCT
[email protected]
03-9656 1268
CML6 (ext study)
Continuing
Lauren Haswell
BaCT
[email protected]
03-9656 5802
CML7
Follow up
Lauren Haswell
BaCT
[email protected]
03-9656 5802
CML8
Open
Lauren Haswell
BaCT
[email protected]
03-9656 5802
CML9
Open
Lauren Haswell
BaCT
[email protected]
03-9656 5802
CML10
Open
Bronwyn Cox
Royal Adelaide
[email protected]
08-8222 3368
HDNHL4
Follow-up
Poppy Kypreos
BaCT
[email protected]
03-9656 1268
HD03
Analysis
Poppy Kypreos
BaCT
[email protected]
03-9656 1268
HD04
Follow-up
Poppy Kypreos
BaCT
[email protected]
03-9656 1268
HD08
Open
Narmatha Kuru
BaCT
[email protected]
03-9656 5807
LY03
Follow-up
Poppy Kypreos
BaCT
[email protected]
03-9656 1268
MDS3
Follow up
Linda Cowan
BaCT
[email protected]
03-9656 3637
MM6
Follow up
Nola Kennedy
Alfred Hospital
[email protected]
03-9276 2217
MM8
Follow up
For information contact Peter Mollee
[email protected]
07-3240 2396
MM9
Follow up
Nola Kennedy
Alfred Hospital
[email protected]
03-9276 2217
MM11
Open
Nola Kennedy
Alfred Hospital
[email protected]
03-9276 2217
NHL13 CORAL
Follow up
Poppy Kypreos
BaCT
[email protected]
03-9656 1268
NHL14 W&W
Follow-up
Poppy Kypreos
BaCT
[email protected]
03-9656 1268
NHL15/TROG 05.02
Open
Marijana Vanevski
BaCT
Marijana Vanevski
03-9656 1143
NHL16
Analysis
Poppy Kypreos
BaCT
[email protected]
03-9656 1268
NHL18
Follow up
Poppy Kypreos
BaCT
[email protected]
03-9656 1268
NHL19 MINT Follow-up
Closed
Cattram Nguyen
BaCT
[email protected]
03-9656 5827
NHL21
Open
Cattram Nguyen
BaCT
[email protected]
03-9656 5827
NHL24
Submitting
Narmatha Kuru
BaCT
[email protected]
03-9656 5807
NHLLOW5/TROG 99.03
Open
Bev McClure
BaCT
[email protected]
03-9656 1266
PT1
Open
Cattram Nguyen
BaCT
[email protected]
03-9656 5827
SCO1 ASPID
Follow-up
Ania Matera
BaCT
[email protected]
03-9656 3661
Page 17
Safety and Data Monitoring Committee
Recent SDMC decisions
The SDMC operates independently and includes at least three external members. The
SDMC reviews all new proposed protocols and must approve each one before it can
proceed to activation. All protocol amendments are reviewed in detail and must also be
approved prior to dissemination to the HRECs at sites. The committee also reviews
regularly all currently accruing trials and closed trials with patients still on treatment.
Summary of decisions from the 19/4/10 SDMC meeting:
New trials approved to be activated
NHL24, ALL7
New trials still under consideration
AMLM15, MDS4
Trial amendments approved:
CLL6, NHL15/TROG 05.02, CML10
Trial reviews - open trials
CML9 (reviewed and continuing)
Trial reviews - recent closures, patients still on treatment
NHL14
For more information on any individual trial, contact the trial coordinators listed on page 9
SDMC Chair
Peter Browett
Thank you to
Devinder Gill who
has recently ceased
his role as Executive liaison for the
SDMC
SDMC Issues
At the May meeting, Peter Browett touched on
some of the issues currently facing the SDMC.
These include:
•
Accrual. Trials with inadequate accrual may
appear futiile and there are resource implications
•
SDMC meetings 2010
Monday 26 July face-to-face, Sydney
Monday 11 Oct teleconference
Stopping rules. These are necessary for
every trial, and should be clear and appropriate. They are primarily to protect study participants
•
Power. This will
be the subject of a
future presentation to
members.
Left: NZ All-Whites
prove that NZ soccer power is superior to Australian
Page 18
SDMC membership
ALLG
Peter Browett (Chair)
Ray Lowenthal
Andrew Grigg
Tony Mills (SAC Liaison)
External
Patrick Kelly (Biostatistician)
Martin Stockler (Medical)
John Stubbs (Consumer Rep)
Alan Herschtal (BaCT Statistician)
Number 29
Regional grant for data management resources - update
The ALLG was successful in a funding grant from the Victorian Cancer Agency in 2009 to provide data management resources for three regional sites - Bendigo, Wollongong and Mater
Newcastle. The reports below show how rapidly an improvement in resources can translate
into improved functioning and increased trial participation.
Bendigo
The funded data manager position was successfully filled and we exceeded our expectations regarding new trial submissions to HREC at Bendigo Health, and allowed us to take
on many more studies, both industry and collaborative. The new person also provided
cover for annual leave and enabled trial staff to develop as a team. All of the proposed
trials included in our submission are now open to accrual. There is an ongoing problem
with lack of physical space for clinical trials staff and files. There are ongoing discussions regarding a short-term
solution to this problem. A new hospital will be built in Bendigo and will accommodate a large research unit
however that is at least 5 years away.
Wollongong
The funding provided by the ALLG regional grant allowed us to increase an existing position to 0.8-1.0 FTE thereby allowing us to increase our recruitment to ALLG trials and
pharmaceutical trials. In 2009-2010, we have 21 clinical trials that are recruiting or at follow up stage compared with 16 studies in 2008. We have been successful with our efforts
to gain access to more pharmaceutical company drug trials including being granted Lead
Site status for ethics coordination for two important studies for myeloma and MDS. The
ground work for regional hospital involvement has been expanded and this has allowed us
to review patients at Shoalhaven Hospital that are enrolled in trials. Also a laptop funded
through the grant will allow data to be stored and used directly in the Haematology outpatients/clinic department. It will also be used at the Shoalhaven Hospital Haematology Outpatients for clinical trials conducted at this site.
Mater Newcastle
Unfortunately there were delays in filling the new position but this has now been accomplished. The new Clinical Trial Coordinator has taken over two current trials from the
Trial Office Manager. This is anticipated to allow the manager more time to assess new
trials and complete accurate feasibility questionnaires (especially to research accurate potential participant recruitment targets). It is anticipated that one of the trials will show an
increase in recruitment as the new CTC will be able to dedicate more time than previously
allocated for active screening of potential participants. The unit manager will now also have
more time to implement more extensive and improved SOP’s and working procedures for the unit.
Page 19
ALLG/Roche QA Partnership
This Partnership is an understanding between Roche
Products and the ALLG to undertake a collaborative
continuous education and quality assurance, has provided many opportunities through the last 3 years.
approach to the constant improvement of clinical
Support for attendance of data managers/research nurses
Contact Janey
research practice in the area of haematological malignancies, under the auspices of the ALLG.
at suitable training courses in GCP. In 2007 22 were
funded, 31 in 2008, 39 in 2009 (36 face-to-face and 3
Stone for
The partnership commenced in January 2007. The
main goal is to develop and maintain a high level of
on-line).
Support for attendance of members (clinicians) at suitable
clinical research practice among people who are
short training courses in GCP. In 2007 10 were funded,
involved in the conduct of clinical research within the
15 in 2008 and 17 in 2009.
ALLG and ensure that research involving human
volunteers is developed and conducted with the
highest level of ethical and scientific quality in order
to minimise human risk and maximise the benefit to
society.
The ALLG/Roche QA Partnership, with a focus on
Funding to assist in the provision of one day educationals
in haematology for data managers/research nurses.
2007 : lymphoma and acute leukaemia
2008 : myeloma and CLL
2009 : NHL and BMT
2010 : CML and ALL
2011 : AML (May)
information
about funding
for GCP courses
in 2010.
It’s not too late
to do the 2 day
DM course in
July
GCP training in 2010
Clinicians/Investigators
Data Managers/Res Nurses
Are you looking for a course to increase your
knowledge and understanding of what GCP means
for your clinical practice? The key to working appropriately in clinical trials is an understanding of the
overall picture and why GCP is important to all parties: sponsors, sites, trial volunteers, ethics and regulators. In addition the course covers the international
perspective including the FDA code of federal regulations and the EU Directive, and how these impact on
your studies.
This year there are three ways you can obtain GCP
triaining.
Topics include:
Details and updates of ICH GCP for Australia
Trial design, documents and processes
Australian and international regulations and ethics
Sponsor/regulatory audits and inspections
The course is provided by Nucleus Network and is
free to all ALLG members. The one day intensive
course will be held Wed 5 May in association with
the Adelaide ALLG Scientific Meeting. Registration
is part of the meeting registration - see page
10.
►
►
►
►
The course will also be held on Wednesday 10 November in conjunction with the November ALLG
Meeting in Sydney.
Two day course
GCP for Research Professionals
Topics include:
►
►
►
►
►
►
►
Development of Investigational Products
Good Clinical Practice (GCP)
HREC and Ethics
Investigator Responsibilities
Informed Consent
Audits & Inspections
Regulatory Environment
Seminars in on-site issues
Nucleus network offers 4 half-day classroom courses
that can stand alone or supplement on-line courses.
The topics are:
► GCP Case Study: examine typical challenges
faced daily in clinical trials
► SOP Writing : covers where to begin, what
format, minimum requirements and includes
templates and resources
► Budgeting, Feasibility and Finance: learn how to
identify factors that determine if a trial will
break even, methods of cash flow, etc
► Research Governance: understand comprehensive key regulatory responsibilities
Please check out the Nucleus Network website for
the calendar and other details.
On-line courses
It is now possible to do the equivalent of the two-day
class room course on line, or to select individual
modules only. See box at right..
Page 20
Number 29
Melbourne University Specialist Certificate in
Clinical Research (Oncology) - 2010
The ALLG scholarship participants have now completed the first module. Coordinated by Michael Jefford,
Peter MacCallum, the course runs over two four-day blocks and involves very intensive study and an exam.
Thank you to Merck, Sharp and Dohme for funding.
After module 1: how are they finding the course?
Michael Jefford
Course coordinator
If you are
unable to attend
a classroom
David Yeung:
“The course comprehensively reviews the principles of trial design with additional information on the ethical and regulatory requirements and the background rationale behind these rules. The lecture material really helps to connect pieces
of disparate information I've gained through clinical experience."
Dipti Talaulikar
“The course is an intensive 2-semester equivalent course which provides a good scientific, ethical, legal and regulatory
framework for those involved in clinical cancer research. Having survived the first module, I have no hesitation in recommending the course. It is well-structured with skilled speakers and real-life practical examples and solutions. It does
require a fair commitment with 2 contact weeks; and the submission deadlines for the various assignments ensure you
remain involved with the course outside contact hours."
James Gray
“I am very much appreciative to the ALLG and Merck Sharp and Dohme for the opportunity to attend the graduate
course "Specialist Certificate in Clinical Research" at Melbourne University. It is organized into a week of contact
teaching in April and another in June. We're now about mid-way, having completed the first week, which was very
intensive with some excellent Melbourne speakers. The course is more intensive than I had initially appreciated with
four assignments and an exam. A fairly substantial amount of work is required and through this I feel that I have
gained a greater depth of knowledge in the principles of clinical trial structure, ethical considerations and good clinical
practice. I feel that this course has helped me improve the quality of my participation as a co-investigator and will give
me more confidence to design a trial of my own”.
Wendy Angelatos
“I very much enjoyed the first module. It was a lot of information some new, some a refresher but all extremely relevant. I was particularly impressed by the standard of the speakers. They were all very experienced in their fields and
from a diverse background.”
based GCP
course, consider
doing one on
line. Contact
Janey Stone if
you are
interested
On-line courses for data managers/research nurses
Below, Penny Mahairas from Nepean tells us about her on-lin experience.
Having had two young children and entering back into the workforce in 2006, I wanted to do some further
education in clinical trials which fitted in with my children and work and which did not involve attending an
institution for any length of time.
I had the opportunity last year to paticipate in an on-line course offered through the ALLG. Perfect !! I have
never had any formal training in clinical trials and only received what was learnt on the job and what has been
offered through ALLG and pharmaceutical company training for specific trials which has been great. I found I
needed something that formally gave information about the clinical trial process. I started the course in July
2009 and have almost completed the two modules which were on Core GCP training and advanced GCP
training. This covered things such as trial budgets, TGA, CTN/CTX applications to name a few. I found it a
wealth of information and even though you learn a lot of these processes on the job you never actually get
formal definitions etc on the way some of these things work. The course is American but wherever possible
the way Australia runs clinical trials was included.
I feel in doing this online course I have got just that: comprehensive information on the processes I needed. I
wish I had this information 15 years ago as it would have helped understand why certain things worked the
way they did. I want to thank the ALLG for offering me this course.
Page 21
New Cancer Australia structure
Cancer Australia, the body that has been determining so much of our funding directions in the last
couple of years, will amalgamate with the National
Breast and Ovarian Cancer Centre (NBOCC), the
Government’s expert centre on breast and ovarian
cancer control.
The press release states that the proposed joint
agency will have a clear leadership mandate across
all cancers, and capacity to better focus on Cancer
Australia’s responsibilities under the Cancer Australia Act 2006.
Some of the intended benefits are as follows:
•
will allow the time, effort and expense spent on
separate reporting requirements and administration to be redirected
•
All cancer stakeholders will have one Australian
Government agency to work with, regardless of
cancer type, and the Government will have one
coordinated source of expert advice on cancer
care.
Consultation with staff, governance bodies and key
stakeholders will be undertaken in June/July as part
of this process. Also a Working Group, chaired by
the CMO, Professor Jim Bishop, will be established
to oversee and advise on the proposed transition. It
will include representation from the NBOCC, Cancer Australia, the Department of Health and Ageing,
and the Cancer Council Australia.
Dr Helen Zorbas has been appointed as the
Chief Executive Officer of Cancer Australia.
Dr Joanne Ramadge will continue to serve as Deputy Chief Executive Officer. Professor Ian Olver,
Chief Executive Officer of Cancer Council Australia,
will continue as the Chair of the Board of Directors
of the NBOCC. Dr Bill Glasson will continue to
serve as Chair of the Cancer Australia Advisory
Council.
Stakeholders and consumers can provide their comments on the amalgamation to the Working Group
via email by 15 July 2010.
NHMRC Strategic Plan 2010-2012
The NHMRC Strategic Plan for 2010-2012 was
recently released. The key objectives of the Plan
derive from National Health and Medical Research
Council Act 1992 and are focussed on health standards, research and ethics.
supporting, renewing and widening Australia’s
pool of talented new researchers, from early
training through to their most productive years.
•
being a good international citizen—contributing
to the development of health knowledge worldwide and improving health in our region through
international research activities.
•
evolving peer review—seeking to achieve the
highest quality decision making through peer
review.
The Plan sets out the NHMRC’s strategy for health
and medical research, which can be summarised as:
•
creating knowledge—by investing in research
most likely to yield new knowledge through
independent research initiated by talented, well
trained researchers.
•
translating knowledge—by supporting funding
schemes that help ensure research findings flow
into improved policy and practice.
•
building capacity to undertake research—by
Read the full NHMRC Strategic Plan for 2010-2012
on the NHMRC website. It delineates the environment within which we will be applying for grants
and other support over the next 3 years.
For everyone who’s missed a deadline….
Page 22
Number 29
Cancer Australia infrastructure grant
It’s hard to believe that the group received its first ever government grant to support infrastructure only 5 years ago from the NHMRC. This enabling
grant provided for the first time some underpinning of the group’s operations and was a vital part of our transformation from a network of clinical
triallists to a modern professional collaborative group. Five years later we have a porfolio of grants, and have applied to Cancer Australia again for
infrastructure funding, with success only recently notified. The ALLG identified the following as our top 5 objectives for the next 3years:
1.
To sustain the Operational and Business oversight for the ALLG
2.
To continue activities that promote professional, public and consumer interactions
3.
To drive the clinical trials development program, from concept to activation.
4.
To facilitate the ALLG trials Safety and Data Monitoring Committee (SDMC)
5.
To support the 2010 Constitution and Board Transition project
The ALLG was successful in gaining 18months of funding ($750k) This will be used to directly support the salaries of the Operations Unit staff including Administration Officer, Business Manager, Quality Coordinator: Grants, Protocol Development Coordinator and Operations Manager.
The Unit currently has some of these roles recruited to, and will advertise shortly the new roles.
Granting bodies - current funding
The ALLG acknowledges funding received during 2009 and 2010 from the following sources:
Cancer Australia
infrastructure, regional program
current to 2010
NHMRC enabling grant
infrastructure, web-based systems, SDMC, training
complete 2010
NHMRC enabling grant (special projects)
Tissue Bank
current to 2011
NHMRC enabling grant (COSA)
clinical trial resources via COSA
complete 2010
Victorian Cancer Agency
infrastructure, regional program
complete 2009
Cancer Australia
infrastructure
current to 2011
PdCCR Scheme
HD8 trial
current to 2012
Grant application updates
Funding body
ALLG project
Status
Outcome due
ACRF
ACRF Centre for Cooperative Cancer Research (with COSA)
COSA/HOTTAH
ALLG Management Database
submitted
end June 2010
LFA
ALL6
submitted
July 2010
LFA
CLL6 (lab studies)
submitted (D Gottlieb)
July 2010
LFA
NHL24 (lab studies)
submitted
July 2010
LFA
AL Amyloidosis
submitted (P Mollee)
July 2010
Cancer Australia/NHMRC
MDS4 (lab studies)
submitted
Oct/Nov 2010
Cancer Australia/NHMRC
NHL24 (lab studies)
submitted
Oct/Nov 2010
NHMRC project grant
ALL6
submitted
Oct/Nov 2010
NHMRC project grant
risk stratified AML
submitted
Page 23
Oct/Nov 2010
Outcome
successful
Lymphoma Research Foundation, Follicular Lymphoma Research Initiative, Clinical studies grant (submitted by TROG)
NHLLOW5/TROG9903
submitted
Page 23
not successful
ALLG Operations Office
The Operations Office staff have begun working with the new Board; introductions and discussions for planning the future. The Board are keen to identify ways to not just improve our current status but to enhance
our position in the community and corporate sectors. Why? clearly because the ALLG has not yet tapped
into what is a great resource of support.
Megan Sanders,
ALLG Protocol
Development Coordinator showing
how happy she is
to help you with
your concept
development
The ALLG clinical trial program is improving as we are able to expand and specialise our working team. The
impact of Megan Sanders as the Protocol Development Coordinator in this past year has been tremendous,
resulting in more investigator initiated concepts converting to actual trial protocols such as CLL6, ALL7,
CML10 and more recently MDS4, ALL6 and AMLM15. The greatest improvement is the translational research proposals that are crucial to your research outcomes. To contact Megan click here.
Membership matters
New members
Nada Hamad
Royal North Shore
Geoff Hill
Royal Brisbane and Women's
Ali Bazargan
St Vincent Hospital, Melbourne
Brendon Kearney Royal Adelaide
Amanda Johnston Westmead
For any membership or
subscription
queries or for
site approval
information
please contact Dilu
Uduwela.
Russell Saal
Dinesh Bhurani
Chris Juttner
Ian Kerridge
Princess Alexandra Hospital
Rajiv Gandhi Cancer Institute
Royal Hobart
Westmead
New site approvals
There have been no new applications since the last newsletter
The ALLG site approval process is designed to ensure that participating sites can safely administer treatment
as per trial protocols and have the resources to provide the associated data management. Due to the limitations of the current site approval process for smaller units, the ALLG Board of Management and the Scientific Advisory Committee is considering whether there is a need to either modify the current process or to
develop a specific approval process for smaller institutions and satellite/outreach sites.
Meanwhile there has been a discussion regarding inactive site. Those sites that have been approved as an
ALLG site but have not enrolled a patient into an ALLG trial for the last 3 years will now need to re-apply. A
letter will be sent to the Principal Investigator of these sites notifying them of the change of policy regarding
site cessation in the near future.
Updated trial insurance certificate
The ALLG will be issuing the updated trial insurance certificate in the coming weeks for no fault coverage for all our trials for period 1/7/10 to
30/6/11
This lists all trials for “no fault” coverage:
► Existing trials that are open
► Trials that we expect to open in the financial period 2010/2011
Page 24
Number 29
The way we were….
This is our regular history corner. If you have an anecdote, some information or topic you would like to
include - or better still contribute - just contact Janey Stone
M
emoires of a Data Manager....
Penny Mahairas (in her previous incarnation Penny Stavros) reminiscences about her 15
years doing trials
“My name is Penny Mahairas and my current position is Clinical Trials Data Manager in Haematology at Nepean
Hospital. I have worked in clinical trials now for about 15 years, ten of those at Westmead Haematology doing
clinical trials. My background is a Bachelor of Science (Biology) and Graduate Diploma in Education Secondary.
Do you have a
memory of the
group’s history
you would like
to share with
others? Send it
to us - we’d
love to print it.
I have really enjoyed working in clinical trials both at Westmead and Nepean Hospitals. I find heamatolgoy extremely interesting and I love being part of the tirals we offer patients with these diseases. I always reminisce with
Janey Stone about one of the first ALLG meetings I went to with Heather Baxter, Janey, Ken Bradstock and Graham Young and about 10 other doctors at RPAH in Sydney in about 1995. I remember Heather and Janey carting
boxes of documents to these meetings with all the relevent protocols etc. How far the ALLG and technology has
come from those days.There must be 200 participants these days and many more trials to go with it. Look forward to the future in haematology trials.”
Times they are a-changin...
With the restrucuture of the group, there have been a number of changes in the occupants of various positions.
Andrew Roberts is now an elected ALLG representative on the Board and has stepped down as co-chair of the
Laboratory Science Committee.
Joy Ho remains co-chair of this committee, and welcomes Maher Gandhi as the new co-chair.
Devinder Gill has completed his term a member of the Executive Committee and is also no longer Disease
Group Co-Chair for Aggressive NHL/HD. Mark Hertzberg will continue as sole Chair of this group. Devinder
has been in leading positions for the ALLG for many years, and has made important contributions during that
time. A special thanks to Devinder from all of us! Devinder will of course continue on as a member and continue
to play a role in the group’s trials in the future.
Pauline Warburton takes up the position of CLLARC liaison.
Andrew Spencer is now an elected ALLG representative on the Board
Peter Bardy also ceased as Executive member and is also now an elected ALLG representative on the Board.
Above: Peter Bardy,
Andrew Spencer and
Pauline Warburton look
over their shoulders...
Left: Devinder Gill and
Maher Gandhi smile at a
bright future
Andrew Roberts pensively contemplates
leaving Joy Ho in charge...
Page 25
Presentations from May Scientific Meeting
Log in and go to News
and Events page
All presentations given at the
May Scientific meeting can
be accessed through our
‘Member Login’ section of
our website under ‘News &
Events’ page. Please note
that these are for your use
and must not be passed on.
ALLG website www.allg.org.au
Scroll down and see
Last Scientific Meeting. Select the day
you wish and click on
“Download agenda
and presentations”
on the right
Select the agenda item
you wish to see and
click on
“Presentation” (in
aqua blue)
This will bring you the
pdf of your selected
presentation.
Page 26
Some people are experiencing issues
with their username and password
when connecting to the Members Only
section of our website through our
new domain name http://
www.allg.org.au. If so here’s what to do
before you log in.
1. Refresh the page
2. Delete cookies by right clicking on
your browser and then click
‘Properties’. Under ‘General’ tab +
‘Temporary Internet Files’, click
‘Delete Cookies’
3. Check to see whether the "Privacy
Report" icon appears at the bottom
right when viewing the ALLG site. If
you see this, then you need to add
our site as an ‘always allow’ site.
Right click on your browser and
then click ‘Properties’. Under
‘Privacy’ tab, click ‘Sites’ button and
then type allg.org.au and click
‘Allow’ button. Again type petermac.org and click ‘Allow’ button.
Then click ‘OK’ button to save your
settings.
Number 29
Publications 2010
ALLG Publications 2010
P. Murray, I. Kerridge, C. Tiley, A. Catanzariti, H. Welberry, C. Lean, S. Sinclair, J. Bishop and K. Bradstock. Enrolment of patients
to clinical trials in haematological cancer in New South Wales: current status, perceived barriers and opportunities for improvement. Internal Medicine Journal 40 (2010) 133–138
A Grigg, J Stone, A Milner, A Schwarer, M Wolf, M Prince, JF Seymour, D Gill, D Ellis and J Bashford. Phase II study of autologous
stem cell transplantation using busulfan-melphalan chemotherapy-only conditioning followed by interferon for relapsed poor prognosis follicular non-Hodgkin lymphoma. Accepted by Leukaemia and Lymphoma 11-1-2010
Christie D, Le T, Watling K, Cornes D, O'Brien P, Hitchins R. Quality assurance audit: a prospective non-randomised trial of chemotherapy and radiotherapy for osteolymphoma (TROG 99.04/ALLG LY02). J Med Imaging Radiat Oncol. 2009, 53::203-6.
NHLLOW1
LY02
ALLG Presentations 2010
J Stone and M Lindenmayer. An interactive database to manage trials and processes for the Australasian Leukaemia and Lymphoma
Group (ALLG). Austrasian Health and Research Data Managers Association Annual Scientific Meeting, Sydney, 25-26 March 2010
(oral presentation)
If your publication or presentation does not appear, it’s not because we don’t like you,
but because we don’t know about it. Please send details to the ALLG Operations Office
to ensure its appearance in the next newsletter.
“Surely you were aware
when you accepted this
position, Professor, that it
was publish or perish?”
ALLG dinner - National Wine Centre
Favourite wines of the outgoing Executive -did you guess right???
Pauline
Andrew
Wei
Leanne
Joy
Tony
Mark
Devinder
John
Ian
Gewurztraminer: because it has musk and rose aromas and can be best enjoyed with her
favourite Thai red curry dish.
Unoaked Chardonnay: because it has a natural peach like fruit flavour & great with his favourite seafood and naturally is crisp and cool just like he.
Dry White: because it has strong gooseberry and lychee fruit aromas, and she can enjoy it
with summer salads.
Shiraz: because it has striking crimson purple colour ~ her favourite colour.
Riesling: because he loves the citrus flavours, but mostly because it can be enjoyed now and
there’s no need to wait for complex old age to drink!
Cabernet Sauvignon: because at 15%Alc/Vol you get 8.9 standard drinks per bottle as
Treasurer he is ensuring best value for money.
Sauvignon Blanc: because with tropical fruit flavours it is versatile (just like he) and is ideal
to enjoy with friends.
Cabernet Shiraz: because Wolf Blass are producing this in recyclable plastic bottles. The
‘Green Label’ the first steps to decrease greenhouse gas emissions, and in a handy recyclable
bottle it is 36% lighter weight and shatterproof.
Merlot: because it is renowned for characters of imagination, fine detail much like himself.
Page 27
News and Views
International Clinical Trials Day
The ALLG has been listed on the 2010 Clinical Trials
Honour Roll, set up to mark International Clinical
Trials Day which was 20 May. We are proud to be
contributing to research that helps advance the
medical care of Australians and New Zealanders.
The day celebrates the clinical trial as a means of
improving health and wellbeing. It seeks to raise
awareness of the importance of research to health
care, and highlights how partnerships between patients and healthcare practitioners are vital to highquality, relevant research. International Clinical Trials
Day began in 2005, as a celebration of the role of
the clinical trial in health and health care. The day
itself commemorates a trial by the eighteenthcentury surgeon James Lind in which he gave a
dozen sailors one of six possible treatments for
scurvy. The interventions included sea water and
vinegar, as well as oranges and lemons. The fruit
turned out to have the best effects. Key passages
from James Lind’s book (1753) are available to view
on the James Lind Alliance website. A range of material of interest to all in clinical trials is available on
the Cochrane Library website in commemoration of
International Clinical Trials Day.
Single ethics review - Victoria
The Consultative Council for Human Research
Ethics (CCHRE) provides governance for the new
system designed to streamline ethical review of
multi-site clinical trials.
The new system aims to:
• Provide a faster, more efficient process to conduct clinical trials at multiple sites and speed up
product development for world markets.
• Improve delivery of new treatments to patients
early in drug/device development.
The CCHRE website has new information useful for
Victorian sites. This includes:
•
Two revised SOPs, for coordinators of HRECs
and Research Governance Officers
• Events page
• Revised Victorian Specific Module (version
31/5/10)
• Templates for reporting and monitoring research
There are now over 60 active HREC applications in
the system in Victoria. In 85% of cases, reviewing
HRECs are approving applications within 30 working days.
Single ethics review - national HoMER Update
The objective of the Harmonisation of Multi-centre
Ethical Review (HoMER) initiative is to enable the
recognition of a single ethical and scientific review
of multi-centre health and medical research within
and/or across Australian jurisdictions.. Current
activities include:
• certicfiation scheme for institutions
Page 28
•
•
web portal development
standardised approach to PICFs and HREC
correspondence
• research governance
Visit the HoMER website for more information
about the project, to view a range of tools and to
participate in consultation processes.
Number 29
CALENDAR
ALLG event
External event
July
26
SDMC face to face, Sydney
August
9
Scientific Advisory Committee face to face, Sydney
September
3
Newsletter deadline
October
12-13
ARCS Conference, Cenberra
12-17
ACCORD Workshop
Sunshine Coast
22
Newsletter published
24
Scientific Advisory Committee teleconference
11
SDMC teleconference
17-20
November
10-12
HSANZ, Auckland
ALLG Scientific Meeting, Sydney
10-12
December
COSA ASM, Melbourne
10
Scientific Advisory Committee face to face, Sydney
26
Newsletter deadline
5-8
15
ASH, New Orleans
Newsletter published
For more
information
about this
event go to
the event
website
(controlclick here)
Page 29
AUSTRALASIAN
LEUKAEMIA
Board
Chair: Peter Kempen
Other independent memebers:
John Mortimore
Malcolm McComas
Geraldine Gray
ALLG members:
John Seymour (Chair SAC)
Andrew Spencer
Andrew Roberts
Peter Bardy
Scientific Advisory
Committee
Chair: John Seymour
Vice Chair Pauline.Warburton
AND
LYMPHOMA
GROUP
The ALLG sponsors trials in malignant haematology in Australia and New Zealand. Trials may be initiated and developed under the auspices of the ALLG or may be international
trials, sponsored in Australia and NZ by the group.
ALLG Operations Office
Level 2,
10 St Andrews Place
East Melbourne, Vic 3002,
Australia
The ALLG is open to all clinicians with a special interest in
trials in malignant haematology. ALLG members may attend
the biannual investigators meetings, receive regular information about activities, and may apply for opportunities for
funding for training and other special projects. All ALLG
members may participate in any ALLG trial, providing their
site is approved for the conduct of ALLG trials.
For further information about joining the ALLG visit the
website or contact Dilu Uduwela.
FUTURE INVESTIGATOR MEETINGS
Operations Staff:
Delaine Smith, Operations Manager
Phone: +613-9656 3656
Email: [email protected]
David Ridler, Business Manager
Phone: +613-9656 3667
Email:[email protected]
Dilu Uduwela: Admin & Events
Phone: +613 9656 3633
Treasurer: Mark Hertzberg
Megan Sanders: Protocol
Secretary: Leanne Berkahn
Andrew Wei
Development
Ian Lewis
Phone: +613 9656 1265
Joy Ho
Janey Stone: QA and Special Projects
Tony Mills
Phone: +613 9656 1265
Disease Group Chairs:
Office Fax: +613-9656 1420
Acute Leukaemia/MDS
Andrew Wei
BMT
Leanne Berkahn, Ian Lewis
CML/MPD
Tony Mills
Aggressive NHL/HL
Mark Hertzberg
Low grade NHL/CLL/MM
Pauline Warburton
9 - 12 November 2010
Novotel Sydney
Brighton Beach
3 - 6 May 2011
Hilton- on-the- Park
Melbourne
Supportive Care
Tony Mills
Laboratory Science
Joy Ho
Liaison roles
Regional: Pauline Warburton
Tissue Bank: Tony Mills
CLLARC: Pauline Warburton
Pathology review: John Seymour
SDMC: Tony Mills
New Zealand: Leanne Berkahn
WA: Gavin Cull
We’re on the Web!
www.allg.org.au
8 - 11 November 2011
Hilton Hotel
Brisbane
Dates for 2012 to be
confirmed

Newsletter June 2010

Transcription

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